Kornimate/medical-research-clean huggingface dataset:
french cohort of covid-19 patients with post-intensive care syndrome

Conditions: Covid19

Summary: the purpose of this study is to describe post-intensive care syndrome (pics) of patients surviving to coronavirus disease 2019 (covid19) and their rehabilitation and recovery process from hospital to home return

the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (sars-cov-2) causing the covid-19 emerged in december 2019 and was declared pandemic in march 2020. although the majority of reported covid-19 cases are mild, approximatively 5% of patients require a stay in intensive care unit, with mechanical ventilation. post intensive care syndrome (pics) consists of physical, cognitive and psychological dysfunctions. little is known about the rate and clinical presentations of pcis among patients surviving to covid-19. the objective of this study is to describe the clinical manifestations of pcis in covid-19 patients, and their rehabilitation process until home return.

Eligibility criteria:
inclusion criteria - patients with covid19 infection : * covid 19 infection (pcr or ct-scan) * icu stay requiring mechanical ventilation * age ≥18 years old inclusion criteria - control group : * age ≥ 18 years old * able to walk without technical assistance, * having no orthopedic or neurological disorder likely to disturb balance and walking * have not had a severe form of covid 19 disease in the last 12 months * collection of non-opposition exclusion criteria: - inability to give consent
accelerated immunosenescence and chronic kidney disease

Conditions: Renal Failure

Summary: the aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent t lymphocytes.

the immunosenescence is a complex and profound remodeling of the immune system during life. it is mainly due to thymic involution and repeated antigenic stimulation. kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population. however, data on aging of the immune system in chronic kidney disease remains incomplete. furthermore, the determinants of immunosenescence are not also not known. it is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact. the purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.

Eligibility criteria:
inclusion criteria: * patient able to understand the reason of the study * patient not opposed to the conservation of biological samples for scientific research exclusion criteria: * patient suffering from psychotic illness * any history of immunosuppressive therapy (except steroids up to 5mg/day) * history of cancer (except skin cancer) or treated hematological malignancy * infectious episode required hospitalization not older 3 months * hepatitis b or c infection * hiv infection, active or inactive * for dialysis patients: renal failure on dialysis for less than 3 months and/or have benefited from two techniques for renal replacement therapy in the last 6 months

Keywords: renal failure dialysis biological aging
epidemiology of gunshot wounds injuries admitted in icu in france

Conditions: Gunshot Wound

Summary: in civilian practice, the incidence of firearm violence depends on the country. in high income countries, most cases are reported in the usa or south africa. in these countries, gunshot wounds (gsw) represent 20% of death cases in trauma centers, more than motor vehicle collisions. the mortality in civilian practice occurs during the first 24 hours following gsw, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown. some factors of mortality specific to gsw have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber. few specific guidelines have been published concerning civilian gsw management. these cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. as in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable. in europe, the incidence of civilian gsw is much lower and few european studies have been published recently. penetrating injuries in europe are less likely to be gsw, and are more often self-inflicted than in the usa. in addition, european studies are heterogeneous, due to the difference in populations, healthcare systems and gsw being grouped with stabbing wounds under the label "penetrating trauma". however, there is a global concern in europe regarding a potential rise of gsw, with higher severity score than conventional trauma patients and often necessitate icu admission. studies analyzing data from different european countries show significantly different icu admission rates for overall gsw, ranging from 17% up to 30%. therefore, the investigators conducted a multicenter, retrospective study on four french university hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian gsw admitted in icu.


Eligibility criteria:
inclusion criteria: * admission for gunshot wound care in icu between 1st of january 2015 and june 30th 2021 at nimes university hospital, marseille north university hospital, montpellier university hospital, toulon military teaching hospital. * patient ≥ 15 years old exclusion criteria: * patient \< 15 years old * patient who objected to the use of their data.
dose response curve - sacral nerve stimulation for faecal incontinence

Conditions: Fecal Incontinence

Summary: the purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with sacral nerve stimulation (sns) for faecal incontinence as stimulation with amplitude at sensory threshold.

faecal incontinence is a devastating condition with huge impact on quality of life. sacral nerve stimulation (sns) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. sns is electrical stimulation of the sacral nerve root(s2,3 or 4). stimulation of this nerve roots results in improved continence. the mechanism of action is at present not well described. standard the neuromodulator (pacemaker) stimulate with frequency 14 hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. one study by sm. koch et all confirms that subsensory stimulation can be effective. at present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation. the aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. this will be investigated in 20 patients who have had at least a reduction in incontinence episodes or wexner inc. score of 75 % between preimplantation and latest follow up. the patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. the order of the three settings will be random and in a double blinded manner. the interval between these three pacemaker settings is four weeks. patients serve as there own controls. stimulation frequency (14 hz) and pulse width (210 mic-sec) will remain fixed. evaluation will be by means of 4 week bowel habit diary and questionnaires (wexner inc. score / st. marks score / wexner constipation score / altomares od-score / ibs-score/ rockwood fiqol -score). all patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.

Eligibility criteria:
inclusion criteria: * 18 years or older * informed consent * idiopathic fecal incontinence or fecal incontinence due to small sphincter defect(≤60 o) * fecal incontinence after primary/secondary sphincter repair * permanent neuromodulator (medtronic interstim / interstim ii) implanted for at least 12 weeks before entering the study. * reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(bowel diary card) or 75% reduction of wexner inc. score. * willing and competent to fill out diary cards exclusion criteria: * colorectal/proctological surgery since ipg-implant * pregnancy * anorectal pain

Keywords: fecal incontinence sacral nerve stimulation quality of life dr15.9 incontinentia alva
impact of endometrial compaction on reproductive outcomes after cryotransfer of euploid embryos in a natural cycle

Conditions: Infertility Due to Nonimplantation

Summary: multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.

multicenter prospective observational cohort study. based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). the main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. the estimated duration of the study is 24-30 months. inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.

Eligibility criteria:
inclusion criteria: * aged 18 to 50 years * primary or secondary infertility * normal uterine cavity * endometrial preparation in a modified natural cycle for single embryo transfer * embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (pgt-a) via trophectoderm biopsy. exclusion criteria: * uterine or endometrial disease (multiple myomatosis \[\>3 fibroids of \> 3 cm\], adenomyosis, asherman syndrome) * difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus * history of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte \[\<35 years\] or oocyte donation); recurrent early pregnancy loss (the loss of two or more pregnancies before 10 weeks of gestational age. * suboptimal endometrial response (endometrium \< 6 mm on the day of ovulation triggering).
post market clinical follow-up for ed coil / electro-detach generator v4

Conditions: Aneurysm; Arteriovenous Malformations; Arterio-venous Fistula

Summary: this is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ed coil and ed detach generator v4.


Eligibility criteria:
inclusion criteria: * patients are over 18 years of age. * patients will undergo catheter embolization using the kaneka ed coil with the ed detach generator v4 for aneurysm, arteriovenous malformation (avm), or arteriovenous fistula (afv) * the patient, or his/her representative, has agreed to the informed consent. exclusion criteria: * the patient, or his/her representative, is unwilling or unable to agree to the informed consent.
prospective construction and validation of a prognostic score to identify among patients with metastatic breast cancer those who benefit from a third line chemotherapy in terms of overall survival

Conditions: Metastatic Breast Cancer Starting a Third Line Chemotherapy

Summary: this is a biomedical study of interventional type. the trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up. this prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer. the main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line. this score will then be validated on the 2nd cohort. there will be no interruption of inclusions between first and second cohort of patients


Eligibility criteria:
inclusion criteria: 1. women of more than 18 years old 2. who 0-4 3. metastatic breast cancer 4. progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy 5. evaluable disease 6. histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and her-2 7. patient able to complete the eortc pal 15 questionnaire 8. patient member in a national insurance scheme 9. informed consent obtained and signed by the patient exclusion criteria: 1. history of other (s) cancer (s) potentially metastatic (s) 2. woman participating in a third line chemotherapy clinical trial 3. pregnant women or nursing mothers can not participate in the study 4. patient under legal guardianship 5. patient unable to undergo medical test for various reasons including social or psychological reasons.

Keywords: breast cancer, third line metastatic chemotherapy, overall survival, quality of life.
t-doc® 5 fr pediatric clinical investigation

Conditions: Incontinence, Urge

Summary: a pivotal study to assess the performance, safety and usability of a new 5 french air-charged catheter for performing urodynamic studies on pediatric subjects


Eligibility criteria:
inclusion criteria: * male and female (children and infants, 12 years of age and younger) * subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician. exclusion criteria: * subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria) * subjects with urethral strictures * subjects who require the use of a suprapubic catheter
histopathological analysis versus full-field optical coherence tomography of minor salivary gland biopsy in suspect sjogren syndrome

Conditions: Sjogren's Syndrome; Tomography Optical Coherence

Summary: primary sjögren syndrome (pss) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. the other clinical manifestations are fatigue and musculoskeletal pain. diagnosis of pss associates clinical abnormalities with specific antibodies (ro/ssa and la/ssb antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. our group recently demonstrated the use of full-field optical coherence tomography (ff-oct) to visualize structural changes associated with the inflammatory processes in giant cell arteritis (temporal artery biopsy examination). it may suggests a further use of dynamic ff-oct of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pss.

this study does not require additional examination, and will use the data performed from the minor salivary gland biopsy carried out as part of usual care, in comparison with the results of the conventional histopathological examination.

Eligibility criteria:
inclusion criteria: * patient \> 18 years of age with suspected sjogren syndrome received minor gland salivary biopsy exclusion criteria: * inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy

Keywords: minor salivary gland biopsy tomography, optical coherence
the cognitive-behavioral approach, standard plan security on relapse suicidal adolescents

Conditions: Treatment of Suicidal Recidivism in Adolescents Population

Summary: the recommendation for the treatment of suicidal adolescents, cognitive behavioral therapy (cbt) targeted new generation offer effective approaches to suicidal crisis and relapse prevention

the recommendation for the treatment of suicidal adolescents, cognitive behavioral therapy (cbt) targeted new generation offer effective approaches to suicidal crisis and relapse prevention. since 2009, our team is engaged in a partnership between france and quebec interuniversity agreement concluded by a university picardie jules verne-university of montreal. in this context, two teams g4 (amiens and rouen) have received training in suicidal crisis, including the security plan by a university instructor and tcc québec, dr. labelle. furthermore, we complete a descriptive and prospective study of risk and protective factors for adolescent suicide in which the quebec team of professor labelle contributes as an expert (sponsor: rouen). 200 subjects were recruited on 2 years by 3 (chu amiens, ch compiègne, chu rouen) with an assessment of recurrence at 1 year (lost rates of view = 15%). the first results highlight the central role of personal coping strategies (coping) in suicidal recurrence. we want extend this study to validate the implementation of the security plan (safety level) with suicidal adolescents. the security plan is the initial step of the tcc approach short of suicidal crisis. it is established after working with adolescents and their families (chain analysis of the suicidal crisis, coping self-evaluation and identification of support resources). developed by stanley b from columbia university and adapted for francophone adolescents r labelle and jj breton wrote this list those resources and coping strategies to apply in case ideation and suicidal crisis. signed by the young person and his family, he then uses to frame the monitoring and management plan of the youth and his family environment, friendly and professional in case of suicidal crisis.

Eligibility criteria:
inclusion criteria: * adolescents between 12 and 17, boys and girls, hospitalized for attempted suicide * adolescents whose parents gave informed consent and who themselves expressed their willingness to participate in research. * patients covered by the social insurance system exclusion criteria: * clinical situations with self-injury without suicidal intent or suicide attempt * mental disorders significantly impair the self-assessment questionnaire capacities: intellectual disability, autism spectrum disorder, acute psychotic state and, psychopathy (including assessment questionnaire frick) and the active use of alcohol and toxic (dep teen\> 20) * have benefited a security plan before the study * adolescents deprived of liberty.

Keywords: cognitive behavioral security plan suicidal recidivism in adolescents
biomechanical assessment of level gait in patient's status post bladder exstrophy

Conditions: Bladder Exstrophy

Summary: the purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. this study is a descriptive analysis of the study cohort's gait patterns and pelvic structure. specific aim 1: to determine whether patients with classic bladder exstrophy who underwent closure demonstrate gait abnormalities. hypothesis 1: patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) demonstrate gait abnormalities compared with a reference population. hypothesis 2: patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) will have below normal functional survey scores.


Eligibility criteria:
inclusion criteria: 1. subject was seen at ccmc for bladder exstrophy between january 2002 and december 2010. 2. subject is four years of age or older at time of enrollment. 3. subject has the ability to walk. 4. subject has not had gait testing performed. 5. subject provides informed consent and hipaa authorization. exclusion criteria: 1. subject was not seen at ccmc for bladder exstrophy between january 2002 and december 2010. 2. subject under four years of age at time of enrollment. 3. subject does not have the ability to walk. 4. subject had prior gait testing performed. 5. subject not willing to provide informed consent and hipaa authorization.

Keywords: bladder exstrophy abnormal gait anatomy urinary bladder disease urogenital abnormalities
paravertebral block for breast surgery

Conditions: Breast Cancer

Summary: the effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

patients having surgery for breast cancer receive a paravertebral blockade at c8-th4 with either naropin 0.5% or saline. general anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. the effect on postoperative pain (\[vas\] and fentanyl pca doses taken) and postoperative nausea and vomiting is recorded.

Eligibility criteria:
inclusion criteria: * breast surgery exclusion criteria: * infections * coagulation disorder * allergy
a pilot study of bms-512148 in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if bms-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control * subjects receiving insulin and metformin and/or a thiazolidinedione * body mass index \<=45.0 kg/m2 * serum creatinine \<1.5 mg/dl for men or \<1.4 mg/dl for women * no overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be \<3 g/24 hrs) exclusion criteria: * history of type 1 diabetes * ast and/or alt \>2.5 times the upper limit of normal * creatinine kinase ≥3 times the upper limit of normal * symptoms of severely uncontrolled diabetes * history of hypoglycemic unawareness * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases